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Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01715246
First Posted: October 26, 2012
Last Update Posted: September 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  Purpose
The primary objective of this clinical study is to show that infants fed a standard starter infant formula with 2 Human Milk Oligosaccharides (HMOs) have a growth in line with infants fed a standard starter infant formula without HMOs.

Condition Intervention
Healthy Other: Infant Formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Clinical Safety of a New Infant Starter Formula Containing 2 Human Milk Oligosaccharides (HMOs)

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Growth [ Time Frame: 4 months of life ]
    child growth (body weight) from enrollment to 4 months of age


Secondary Outcome Measures:
  • Growth [ Time Frame: 6 and 12 months of age ]
  • Digestive tolerance (stool charecteristics, bowel movements,behavior patterns) [ Time Frame: every month during 6 months ]
    Parents are asked to complete a diary on digistive tolerance of their child

  • Product compliance (quantity of formula in ml consumed on the 3 days before visit) [ Time Frame: every month for 6 months ]
    Parents are asked to complete a diary on the product compliance

  • Morbidity [ Time Frame: ongoing for 1 year ]
  • Stool microbiota [ Time Frame: 3 and 12 months of age ]
  • Gene expression [ Time Frame: 3 and 12 months of age ]

Estimated Enrollment: 176
Study Start Date: October 2012
Study Completion Date: July 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Starter infant formula without HMO
Volumes of feed depend on age, weight and appetite.
Other: Infant Formula
Active Comparator: Starter infant formula with 2 HMOs
Volumes of feeds depend on age, weight and appetite
Other: Infant Formula
No Intervention: Breasfed reference group

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy babies
  • Full term babies (37 weeks ≤ gestation ≤ 42 weeks)
  • birth weight between 2500 g- 4500g
  • Having obtained the baby's legal representative's informed consent.
  • FF groups:

babies aged between birth and 14 days, exclusively formula-fed at time of enrollment, whose mother independently elected, before enrollment, not to breastfeed

• BF group: babies aged 3 months (+/- 5 days), exclusively breastfed since birth.

Exclusion Criteria:

  • Congenital illness or malformation that may affect growth
  • Significant pre-natal and/or serious post-natal disease before enrollment (by medical decision)
  • Minor parent(s)
  • Newborn whose parents / caregivers cannot be expected to comply with study procedures
  • Currently participating or having participated in another clinical trial since birth, except for BF group, where vaccines studies are allowed.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715246


Locations
Belgium
Kinderartsenpraktijk
Hasselt, Belgium, 3500
Italy
Dipartimento Materno Infantile
Palermo, Italy, 90127
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Giovanni CORSELLO Dipartimento Materno Infantile, Palermo
Principal Investigator: Philippe ALLIET Kinderartsenpraktijk, Hasselt, Belgium
  More Information

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01715246     History of Changes
Other Study ID Numbers: 11.26.INF
First Submitted: October 24, 2012
First Posted: October 26, 2012
Last Update Posted: September 11, 2015
Last Verified: July 2014

Keywords provided by Nestlé:
healthy babbies
infant formula
growth
HMO